Skip to content

Magly 6.5MM Cannulated Screws

by Magly Orthopedics, LLC

510(k) K021662

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021662 Date12 Aug 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Magly 6.5mm Cannulated Screws are orthopedic fixation devices classified as a cancellous screw (HWC) under FDA nomenclature. These titanium alloy screws feature a cannulated design for guided insertion via a guide wire, ensuring precise placement within large bone fractures. The distal tip includes 20mm of thread with five cutting flutes for reaming and tapping, while the shank incorporates two reverse cutting flutes to aid in screw removal.

Intended for large bone fracture stabilization, these screws are supplied sterile and are reusable within their intended clinical setting. The device is MRI-unsafe due to its metallic composition and must be handled according to standard orthopedic surgical protocols. Available exclusively in the 6.5mm diameter size, they require proper storage in a clean, dry environment to maintain sterility and integrity. The device holds an FDA 510(k) clearance (K021662) under the Traditional 510(k) Review pathway, with a decision date of August 12, 2002.

Other devices from Magly Orthopedics, LLC

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary use of the Magly 6.5mm Cannulated Screws?

    These screws are designed specifically for stabilizing large bone fractures. The cannulated design allows for guided insertion over a guide wire, ensuring accurate placement within the bone. The distal tip features 20mm of thread with five cutting flutes to ream and tap the bone, while the shank includes two reverse-cutting flutes to facilitate easier removal if needed.

  • Are the Magly 6.5mm Cannulated Screws single-use or reusable?

    The Magly 6.5mm Cannulated Screws are reusable within their intended clinical setting. This means they can be used multiple times in surgery as long as they are properly cleaned, inspected, and maintained according to standard orthopedic surgical protocols.

  • What size and material are these screws made of?

    These screws are available exclusively in a 6.5mm diameter size and are manufactured from titanium alloy. The material choice provides a balance of strength and biocompatibility, suitable for orthopedic fixation applications.

  • How should the Magly 6.5mm Cannulated Screws be stored?

    To maintain sterility and integrity, these screws must be stored in a clean, dry environment. Proper storage conditions are critical to ensure the device remains uncontaminated and functional for clinical use.

  • Are these screws MRI-safe?

    No, these screws are MRI-unsafe due to their metallic composition. If MRI imaging is required in a patient with these screws, the metallic components could interfere with the imaging process and pose safety risks.